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The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel

Sponsor
Jiangsu vcare pharmaceutical technology co., LTD (Industry)
Overall Status
Completed
CT.gov ID
NCT03599284
Collaborator
(none)
279
Enrollment
27
Locations
4
Arms
10.9
Actual Duration (Months)
10.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention （PCI） will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days. The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease during and after PCI compared with clopidogrel.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vicagrel 5mg
  • Drug: Vicagrel 6mg
  • Drug: Vicagrel 7.5mg
  • Drug: Clopidogrel 75mg
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
279 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel in Patients With Coronary Atherosclerotic Heart Disease and Planned Percutaneous Coronary Intervention: a Multi-center, Randomized, Double-blind, Triple-dummy , Parallel-controlled, Dose-exploration Phase II Trial
Actual Study Start Date :
Aug 30, 2018
Actual Primary Completion Date :
Jun 11, 2019
Actual Study Completion Date :
Jul 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group 1

Experimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days

Drug: Vicagrel 5mg
Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
Experimental: Experimental group 2

Experimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days

Drug: Vicagrel 6mg
Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
Experimental: Experimental group 3

Experimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days

Drug: Vicagrel 7.5mg
Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Active Comparator: Control group

Control group: Clopidogrel 300mg loading followed by 75mg/day for 28 days

Drug: Clopidogrel 75mg
Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days

Outcome Measures

Primary Outcome Measures

  1. Inhibition of platelet aggregation [28 days after treatment]

    Inhibition of platelet aggregation will be assessed by Verifynow System

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male and female aged 18-75.

  • Weight ≥ 50 kg

  • Patients with coronary atherosclerotic heart disease diagnosed clinically and planned percutaneous coronary intervention

  • Patients with ability and willingness to sign informed consent and adherence to trial protocol.

Exclusion Criteria:

  • Hemorrhagic symptoms (such as hematemesis, melena, severe or recurrent epistaxis, hemoptysis, marked hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected vascular malformations (such as aneurysms), or abnormal bleeding history (such as abnormal hemorrhage attributed to tooth extraction), himself or his immediate family with coagulation or bleeding disorders (such as hemophilia);

  • Non-ST-segment elevation acute coronary syndrome (<2h emergency PCI), or ST-segment elevation myocardial infarction within 7 days;

  • Patients with suspected aortic dissection;

  • Patients with negative coronary Computed Tomography angiography（CTA）(coronary CTA depending on investigator);

  • Patients with severe disease and life expectancy <1 year;

  • Patients with acute peptic ulcer;

  • History of hemorrhagic stroke or history of ischemic stroke within 6 months before screening and a definite diagnosis of structural abnormalities in the central nervous system;

  • Patients with uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg) after drug treatment during screening;

  • One of the following conditions: cardiogenic shock, chronic congestive heart with failure New York Heart Association (NYHA) grade ≥ III grade or left ventricular ejection fraction determined by echocardiography < 35%, hypotension (systolic pressure < 90 mmHg and or diastolic pressure < 60 mmHg), severe arrhythmias (including high-degree atrioventricular block, sick sinus syndrome, persistent ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, and hepatic insufficiency (ALT or AST caused by non-cardiac diseases exceeding the upper limit of normal by more than 3 times), severe renal insufficiency (eGFR < 30 ml/min), cirrhosis;

  • Patients Received P2Y12 receptor antagonist and Ⅱb/IIIa receptor inhibitor, oral anticoagulant (warfarin, rivaroxaban, dabigatran, etc.) within 14 days before screening;

  • Prolonged cardiopulmonary resuscitation (more than 10 minutes) or severe trauma within 2 weeks before screening;

  • Patients plan to undergo another surgery within 1 month after participating in this trial，or plan to undergo PCI procedure performed several times during the test (except for the end of the safety follow-up);

  • History of severe allergies, non-allergic drug reactions or allergies to 2 or more drugs (including contrast agents), or known allergies to the similar drugs (clopidogrel, ticagrelor) as the study drug or contraindication of aspirin;

  • Patients with mental disorders or alcohol dependence;

  • Patients being receiving any experimental medicine or experimental medical devices;

  • Prothrombin time (PT)> 1.3 times the upper limit of normal or international normalized ratio (INR)> 2.0;

  • Platelet count (PLT) < 100×109/L or > 600×109/L;

  • Hemoglobin < 10g/dL;

  • Patients who cannot tolerate dual antiplatelet therapy for 28 days;

  • Female of reproductive age with positive blood pregnancy test;

  • Female with gestational intention or in lactation;

  • Other unsuitable conditions considered by investigators.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital Bengbu Medical College Bengbu Anhui China 233004
2 Beijing Anzhen Hospital, Capital Medical Universily Beijing Beijing China 100029
3 Guangdong General Hospital Guangzhou Guangdong China 510030
4 First Affiliated Hospital of Zhongshan University Guangzhou Guangdong China 510080
5 First Hospital of Hebei Medical University Shijiazhuang Hebei China 050100
6 Wuhan Asia Heart Hospital Wuhan Hubei China 430022
7 Changsha Central Hospital Changsha Hunan China 410004
8 Xiangya Hospital of Central South University Changsha Hunan China 410008
9 Second Xiangya Hospital of Central South University Changsha Hunan China 410011
10 Third Xiangya Hospital of Central South University Changsha Hunan China 410013
11 Affiliated Drum Tower Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008
12 Zhongda Hospital of Southeast University Nanjing Jiangsu China 210009
13 Jiangxi Provincial People's Hospital Nanchang Jiangxi China 330006
14 First Hospital of Jilin University Changchun Jilin China 130021
15 Second Hospital of Jilin University Changchun Jinin China 130041
16 the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army（The General Hospital of Shenyang Military） Shenyang Liaoning China 110015
17 The People's Hospital of Liaoning Province Shenyang Liaoning China 110015
18 Shengjing Hospital of China Medical University Shenyang Liaoning China 110134
19 Qinghai Provincial People's Hospital Xining Qinghai China 810007
20 Yuncheng Central Hospital Yuncheng Shanxi China 044000
21 Affiliated Hospital of Southwest Medical University Luzhou Sichuan China 646000
22 Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
23 Sir Run Run Shaw Hospital Hangzhou Zhejiang China 310020
24 China-Japan Friendship Hospital Beijing China 100029
25 Peking Union Medical College Hospital Beijing China 100032
26 Tianjin Medical University General Hospital Tianjing China 300052
27 Tianjin People's Hospital Tianjin China 300121

Sponsors and Collaborators

  • Jiangsu vcare pharmaceutical technology co., LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu vcare pharmaceutical technology co., LTD
ClinicalTrials.gov Identifier:
NCT03599284
Other Study ID Numbers:
  • VCP1-Ⅱ-01
First Posted:
Jul 26, 2018
Last Update Posted:
Sep 23, 2019
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronary Artery Disease
Clopidogrel

Study Results

No Results Posted as of Sep 23, 2019